One of the fundamental tenets of Good Clinical Practice is that foreseeable risks and inconveniences of a trial should be weighed against the anticipated benefit to the individual trial subject and society. But what happens when an experimental drug is considered not to be a benefit for the society in which it is being tested?
The Philippine Department of Health has ruled that a trial of the drug, TriAct, has no legal basis to be in the Philippines as it may be of little long-term benefit to Filipinos.
The drug is a potential treatment for malaria, and dengue fever, which is a major problem in The Philippines. The disease is cited as a leading cause of childhood hospitalisations and has reached epidemic proportions in the past.
So why the objection to the trial of a new treatment?
The experimental drug regimen consists of a single use of a sublingual spray combined with doses of artesunate and berberine tablets, both of which are derivatives of artemisium. Artemisium has been used as an anti-malarial in Chinese medicine for over 5,000 years.
TriAct was being hailed as a breakthrough drug in the Philippine press a few weeks ago but now the Department of Health has halted trials due to potential “long term harmful effects.”
The DoH claims that the trial design was “highly irregular and dangerous” as it did not adequately follow the protocols for human trials enshrined in Good Clinical Practice.
It seems that there are still several vocal supporters of TriAct in the Philippines so this is not likely to be the last word…
|
|
 |
|
|
Share on LinkedIn |
